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Equivalency Study of the TEG and CORA Hemostasis Systems

NCT01790386 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 465

Last updated 2013-12-17

No results posted yet for this study

Summary

This study is being performed to obtain data about the CORA system, a new device that is currently being tested and is not yet cleared for sale in the United State by the Food and Drug Administration (FDA). The purpose of the study is to validate the CORA system by comparing the results of this test to that of the standard of care device called the TEG system. Both systems evaluate hemostasis, a highly complex and interactive process involving many protein and cellular elements, especially platelets, occurring in a series of interrelated phases, which results in either normal hemostasis or a tendency toward bleeding or clotting complications.

Conditions

  • Heart Disease
  • Focus is on Testing Performance of CORA Hemostasis System.

Sponsors & Collaborators

  • Coramed Technologies LLC

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01790386 on ClinicalTrials.gov